At a glance
- What the study gets you
- Health checks and monitoring — no treatment given
- Type of study
- Observational (no treatment given)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Not specified by the sponsor
- How long the study runs
- Study runs about 72 months (dates as stated)
- About the drug or intervention
- Not specified by the sponsor
- Patient visit burden
- Not specified by the sponsor
In plain English
This study looks at people who had an ischaemic stroke (a stroke caused by a blockage of blood flow to the brain) while already taking blood-thinning tablets called oral anticoagulants. The researchers want to learn more about these strokes and how outcomes are assessed, in patients who also have atrial fibrillation (AF) or a similar heart rhythm problem.
Who can take part
- Adults aged 18 or over who have had an ischaemic stroke
- Stroke confirmed by a brain scan (CT or MRI) showing one or more areas of damage that match the person's symptoms
- Already taking blood-thinning tablets when the stroke happened. For newer tablets (direct oral anticoagulants), the last dose must have been within 48 hours before stroke symptoms started. For warfarin-type medicines (vitamin K antagonists), a blood clotting test (INR) result of 1.5 or higher
- Previously diagnosed with atrial fibrillation (an irregular heartbeat) or a similar heart rhythm problem that can cause clots
Who may not be able to
- Symptoms that do not point to an acute stroke, such as fainting, shaking or jerking movements, dizziness alone, confusion or memory loss alone, or nerve problems that developed slowly over time
- Receiving blood-thinning treatment by injection or drip (including heparin 'bridging' when starting warfarin-type medicines) at the time of the stroke
What taking part involves
- • Not stated — ask the trial team. This study observes people who have already had a stroke; no study treatment is described.
Time commitment: Not stated — ask the trial team, as the registry entry does not describe visits, duration, or what taking part involves.
Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.
- Type of study
- Observing health over time
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 200
- Started
- 2025-02-12
- Last checked
- 2025-02
Plain English Summary
What is this study?
- • Testing a new treatment for ischemic stroke
- • Clinical study - 200 participants
- • The Advancing knowledge in ischemic Stroke PatiEnts on oRal Anticoagulants (ASPERA) study aims to investigate characteristics of ischemic stroke cases occurring in patients on oral anticoagulation for atrial fibrillation (AF) or other cardioembolic arrhythmias and to characterize short and long-term outcomes associated with different secondary prevention strategies to prevent stroke recurrences
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with ischemic stroke
Where?
- • Bristol - Southmead Hospital, North Bristol NHS Trust
- • London - St George's University Hospitals NHS Foundation Trust
- • London - Department of Brain Sciences, Imperial College London
- • London - Department of Stroke and Neuroscience, Charing Cross Hospital, Imperial College
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
The Advancing knowledge in ischemic Stroke PatiEnts on oRal Anticoagulants (ASPERA) study aims to investigate characteristics of ischemic stroke cases occurring in patients on oral anticoagulation for atrial fibrillation (AF) or other cardioembolic arrhythmias and to characterize short and long-term outcomes associated with different secondary prevention strategies to prevent stroke recurrences. The ASPERA study is a multicenter, observational, both retrospective and prospective real-world study involving acute ischemic stroke patients occurring on oral anticoagulation. The study will encompass a retrospective (ASPERA-R) and prospective (ASPERA-P) data collection. Patient will be recruited consecutively at different emergency services and stroke units worldwide. University of L'Aquila (UnivAQ) will be in charge of study coordination, data analysis and management. The duration of ASPERA-R will be of 5-year from the study initiation of the study. Participating centers will be given a 6-month timeframe to enter retrospective data, commencing from the date of study approval. ASPERA-P duration will be of 2 years of enrollment from the study approval and follow-up of 5 years. (study conclusion after 7 years of approval). Inclusion criteria will be: 1.Confirmed diagnosis of ischemic stroke. 2. Availability of at least one neuroimaging exam positive for ischemic lesion(s) consistent with patient symptoms. 3. Ongoing oral anticoagulation at the time of the index ischemic stroke. 4. Prior diagnosis of atrial fibrillation or other cardioembolic arrhythmias. 5. Written informed consent provided by the patient himself or by proxy. Patients with Symptoms not indicative of acute stroke, ongoing intravenous or subcutaneous anticoagulation at the time of stroke will be excluded. ASPERA-R: characterization of demographic, clinical and neuroimaging features of ischemic stroke cases occurring on oral anticoagulants. The primary outcome will be: ASPERA-R : characterization of demographic, clinical and neuroimaging features of ischemic stroke cases occurring on oral anticoagulants. ASPERA-P: risk of ischemic stroke recurrence of ischemic stroke cases occurring on oral anticoagulants across different secondary preventive strategies (i.e., maintaining the same type of oral anticoagulation versus switching to a different secondary prevention strategy) at 90 days, 1 and 5 years after the index stroke. Additionally, the study will aim to investigate the risk of safety events (hemorrhagic transformation, intracranial hemorrhage, other major bleeding events, any bleeding events, death due to any cause), risk of other major ischemic events (transient ischemic attack, myocardial infarction, death due to vascular causes) at each follow-up and to identify demographic, clinical and neuroimaging features of ischemic stroke recurrences.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
What the study is looking for
- ✓Age ≥18 years at the time of the index ischemic stroke.
- ✓Confirmed diagnosis of ischemic stroke according to the World Health Organization (WHO) definition.
- ✓Prior diagnosis of AF or other cardioembolic arrhythmias.
Who cannot take part
- ✗Symptoms not indicative of acute stroke (i.e., syncope, tonic or clonic activity, dizziness alone, confusion and...
- ✗Ongoing parenteral (intravenous or subcutaneous) anticoagulation at the time of the index event, including bridging...
See the full criteria
Where Is This Study? (4 UK sites)
Southmead Hospital, North Bristol NHS Trust
Bristol BS10 5N, United Kingdom
St George's University Hospitals NHS Foundation Trust
London SW17 0QT, United Kingdom
Department of Brain Sciences, Imperial College London
London W12 0NN, United Kingdom
Department of Stroke and Neuroscience, Charing Cross Hospital, Imperial College
London W6 8RF, United Kingdom
How to Get in Touch
Simona Sacco, MD
Sponsor contactCONTACT
Matteo Foschi, MD
Sponsor contactCONTACT